With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. Read More
Aavantibio Inc., with the help of a large check from Sarepta Therapeutics Inc., has launched with a $107 million series A to pursue gene therapies for treating rare genetic diseases. The lead program is in Friedreich’s ataxia (FA), a rare genetic disease that typically begins in childhood and causes progressive damage to the nervous system. Read More
Be Biopharma Inc. is looking to develop engineered B cells to treat a wide range of diseases. The new category of cellular medicine is based on the work of David Rawlings and Richard James, researchers at Seattle Children’s Research Institute and the University of Washington. Read More
LONDON – Araris Biotech AG has raised CHF12.7 million (US$16.8 million) in a seed funding round to take forward what it claims is the holy grail for antibody-drug conjugates (ADCs), a linker technology that allows for the attachment of any payload to any antibody, without the need for engineering. Read More
Researchers at Israel’s Ben-Gurion University have launched a machine learning platform that aims to streamline the clinical trial process using predictive analytics. The technology has been licensed to Panacea, a startup company formed by BGN Technology. Read More
Roche Holding AG, already advancing multiple therapies and diagnostics for COVID-19, is adding its support for Boston-based Atea Pharmaceuticals Inc.'s AT-527 to the lineup. Read More
Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir). Read More
The Chinatrials roundtable went virtual this year and drew clinical trial experts to discuss state-of-the-art clinical trial design strategies, which are increasingly important in a more competitive clinical landscape. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Adicet, F2G, Gilead, Leo, Nevakar, Reven. Read More
